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DECISION

Promulgating the Regulation on the import of drugs without registration number in Vietnam

THE PRIME MINISTER

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the June 14, 2005 Pharmacy Law;

Pursuant to the December 22, 2000 Law on Narcotics Prevention and Combat;

At the proposal of the Minister of Heath,

DECIDES:

Article 1.- To promulgate together with this Decision the Regulation on the import of drugs without registration number in Vietnam.

Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO." All previous regulations contrary to this Decision are annulled.

Article 3.- The Minister of Health shall guide and implement this Decision.

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, and presidents of provincial/municipal People's Committees shall implement this Decision.

Prime Minister
NGUYEN TAN DUNG

REGULATION ON THE IMPORT OF DRUGS WITHOUT REGISTRATION NUMBER IN VIETNAM

(Promulgated together with the Prime Minister's Decision No. 151/2007/QD-TTg of September 12, 2007)

Chapter I

GENERAL PROVISIONS

Article 1.- Governing scope

1. This Regulation provides for the import of drugs without registration number in Vietnam (referred to as drugs without registration number) in the following cases:

a/ They are composed of pharmaceutical ingredients with or without registration number, which are, however, insufficient to meet medical treatment needs;

b/ They are imported to meet urgent needs of epidemic prevention and combat and overcoming of consequences of natural disasters, and special medical treatment needs;

c/ They are imported for national target health programs;

d/ They are donations or humanitarian aid;

e/ They are imported for clinical trial, for use as registration samples or for display at exhibitions or fairs;

f/ They are imported as non-commercial goods for research and testing.

2. Drugs which are carried along for personal medical treatment comply with the Prime Minister's Decision No. 71/2002/QD-TTg of June 7, 2002, on the management of curative drugs for human use which are imported or exported through non-commercial channel.

Article 2.- Subjects of application

This Regulation applies to Vietnamese traders; foreign traders; foreign traders supplying drugs to Vietnam; organizations and individuals engaged in the import of drugs without registration number in Vietnam or the provision of drugs without registration number in Vietnam as aid or humanitarian aid.

Article 3.- Principles of management of drugs without registration number imported into Vietnam

Drugs without registration number may only be imported under import permits. A permit for the import of drugs without registration number is valid for one year at most after its signing.

Article 4.- Conditions on Vietnam traders importing drugs without registration number

Drug-manufacturing or -wholesaling enterprises which have a certificate of satisfaction of drug-trading conditions and drug warehouses meeting Good Preservation Practice standards may import drugs in accordance with the law on pharmacy, the Health Ministry's regulations and relevant legal provisions.

Article 5.- Conditions on foreign traders supplying drugs without registration number to Vietnam

Foreign traders supplying drugs without registration number to Vietnam must have licenses for operation in Vietnam granted by the Health Ministry. In case foreign enterprises having such operation licenses do not supply drugs which are needed for disease prevention and treatment, the Health Minister shall consider and decide to permit the import of these drugs from prestigious drug suppliers in the world.

Article 6.- General provisions on drugs without registration number imported into Vietnam

1. Drug quality

Foreign traders manufacturing or supplying drugs; drug-importing traders; and traders ordering or undertaking the entrusted import of drugs shall take responsibility for the quality and safety of imported drugs according to the Pharmacy Law, the Commercial Law, the Health Ministry's professional regulations on drug quality management and other relevant legal provisions.

2. Use duration of drugs

a/ Finished drugs without registration number imported into Vietnam must have a remaining use duration of at least 18 months, counting from the date of arrival at a Vietnamese port. For drugs with a use duration of 24 months or less, the remaining use duration must be at least 12 months, counting from the date of arrival at a Vietnamese port;

b/ Vaccines or medical biologicals without registration number must have a remaining use duration of at least equal to two thirds of their prescribed use duration, counting from the date of arrival at a Vietnamese port;

c/ Drug raw materials without registration number imported into Vietnam must have a remaining use duration of over three years, counting from the date of arrival at a Vietnamese port, for raw materials with a use duration of three years or less, they must arrive at a Vietnamese port within six months from the date of manufacture. This provision does not apply to pharmaceutical ingredients;

d/ In case drugs fail to comply with the provisions of Points a, b and c, Clause 2, of this Article on use duration, but need to be imported for medical treatment or domestic manufacture, the Health Minister shall consider, make decisions and take responsibility for his/her decisions.

3. Labels of imported drugs without registration number

Labels of imported drugs without registration number must comply with the Government's Decree No. 89/2006/ND-CP of September 30, 2006, on goods labeling, Article 37 of the Pharmacy Law, and the Health Ministry's regulations on drug labeling.

4. Declaration of prices of imported drugs without registration number

When submitting dossiers of the import of drugs without registration number, depending on the business form, wholesale or retail, applicable to each drug, drug-importing establishments shall declare import prices and projected wholesale and retail prices in Vietnam according to the law on state management of drug prices.

5. The import of drugs without registration number on the list of drugs banned from import promulgated by the Health Ministry is strictly prohibited.

Chapter II

SPECIFIC PROVISIONS ON THE IMPORT OF FINISHED PRODUCTS WITHOUT REGISTRATION NUMBER

Article 7.- For finished drugs without registration number defined at Points a, b and c, Clause 1, Article 1, of this Regulation

1. To be permitted for import into Vietnam, finished products without registration number defined at Points a, b and c, Clause 1, Article 1 must meet the following conditions:

a/ They are permitted by a competent state management agency of the manufacturing country for circulation in this country. In case enterprises of different countries are engaged in the manufacture of a single product, this product must be permitted by a competent state management agency of at least one of these manufacturing countries for circulation in this country.

b/ Drug-manufacturing establishments must possess a "Good Manufacture Practice" certificate granted by a competent state management agency of the manufacturing country;

c/ The Health Minister may consider and permit the import of drugs which are manufactured only for export but needed for medical treatment;

d/ Finished products containing habit-forming drugs, psychotropics and pre-substances which are used as drugs without registration number, must comply with this Regulation, the Health Ministry's professional regulations and other relevant legal provisions;

e/ Drugs without registration number which are new drugs specified in Clause 18, Article 2, of the Pharmacy Law and not entitled to exemption from clinical trial or a number of stages of clinical trial as specified in Article 55 of the Pharmacy Law but needed for medical treatment may be considered for import after clinical trials are completed and all regulations of the Health Ministry on clinical trials are complied with.

2. Drugs without registration number (containing pharmaceutical ingredients with or without registration number), which are insufficient to meet medical treatment needs, apart from having to comply with the provisions of Clause 1 of this Article, must fall into one of the following cases:

a/ They are composed of pharmaceutical ingredients of groups with pharmacological effects or preparation forms with few registration numbers for circulation in Vietnam according to the list of drugs with registration number for circulation in Vietnam in each period;

b/ They are composed of pharmaceutical ingredients with registration number for circulation in Vietnam but at the time of submission of import dossiers, these registration numbers have expired without registration renewal;

c/ They are composed of pharmaceutical ingredients which have been permitted for circulation in other countries but are not yet been granted a registration number in Vietnam, except new pharmaceutical ingredients;

d/ They are rare drugs, specific drugs or drugs of special preparation forms which cannot be yet manufactured in Vietnam.

3. Quantity of drugs permitted for import:

a/ Drugs composed of pharmaceutical ingredients with or without registration number which are insufficient for medical treatment may be permitted for import in a quantity enough for medical treatment on a case-by-case basis;

b/ Finished drugs without registration number imported to meet urgent needs of epidemic prevention and combat or overcoming of consequences of natural disasters may be imported in a quantity determined on the basis of competent health agencies' certification of the situation of epidemics or natural disasters as well as the drug demand;

c/ Finished drugs without registration number imported for special treatment needs of hospitals may only be imported in a quantity determined according to these hospitals' estimates and used for in-patients and out-patients under physicians' prescription but not for sale on the market.

d/ Finished drugs without registration number imported for national target health programs may be imported in a quantity determined according to relevant legal documents on the import of drugs under national health programs and projects. Drugs of national health programs and projects must be imported through entrustment by enterprises satisfying the conditions specified in Article 4 of this Regulation. Drug labels must show the phrase "Drugs of national health programs" or "Drugs of national health projects."

Article 8.- For finished drugs without registration number defined at Point d, Clause 1, Article 1, of this Regulation

1. Aid or humanitarian aid drugs are drugs presented or donated by charity organizations, non-governmental organizations, foreign individuals or overseas Vietnamese (referred to as foreign parties) to localities, ministries, branches, medical treatment establishments and organizations of Vietnam (referred to as aid-benefiting units) in the form of donation, humanitarian aid or urgent aid in service of disease prevention and treatment.

2. Aid or humanitarian aid drugs must meet the following requirements:

a/ Being permitted for circulation in manufacturing countries. Vaccines and medical biologicals must be on the list of vaccines and medical biologicals the use of which is encouraged by the World Health Organization;

b/ Satisfying practical needs of aid-benefiting units and national policies on drugs of Vietnam;

c/ Not being on the list of habit-forming drugs or list of drugs banned from import into Vietnam;

d/ Being of clear origin and meeting quality, safety and effect standards of aid-providing countries and Vietnam. Each lot of vaccines and medical biologicals must have a certificate of quality standard conformity granted by the national assay agency of the manufacturing country or a competent agency and, at the same time, have their quality evaluated by the National Vaccine and Medical Biologicals Assay Institute before being imported;

e/ Being packaged in proper packings showing the appellations of drugs, active ingredients, contents, preparation forms and packaging specifications, with drug use instructions and detailed lists accompanying each packing unit.

f/ Use duration of drugs

For aid or humanitarian aid drugs with a use duration of two years or more, the remaining use duration must be at least one year, counting from the date of arrival at a Vietnamese port. For drugs with a use duration of less than two years, the remaining use duration must be equal to at least one third of the prescribed use duration, counting from the date of arrival at a Vietnamese port.

3. In special cases, aid drugs in service of research programs which fail to meet the conditions specified in Clause 2 of this Article may be considered and permitted for receipt on the basis of relevant legal and technical documents of those research programs.

Article 9.- For finished drugs without registration number specified at Points e and f, Clause 1, Article 1, of this Regulation

1. Drugs imported for clinical trial must comply with the Health Ministry's regulations on clinical trial of drugs, the quantity of imported drugs must conform with the scheme on clinical trial of drugs approved by the Health Minister. These drugs must be used in strict accordance with the approved research scheme.

2. Each kind of drug imported for use as samples for registration for circulation in Vietnam may be imported in five packing units or less similar to those for circulation.

3. Drugs imported for display at exhibitions and trade fairs must comply with the following regulations:

a/ They have been granted circulation permits in the exporting countries;

b/ They are used for the purposes of display at exhibitions or trade fairs only;

c/ The temporary import and re-export must be carried out in strict accordance with the Commercial Law and a report on the quantity of re-exported drugs must be sent to the Health Ministry after the re-exportation,

4. Drugs imported for research and testing must be used for research or testing purposes only and in quantities suitable to these purposes.

Chapter III

SPECIFIC PROVISIONS ON THE IMPORT OF DRUG RAW MATERIALS WITHOUT REGISTRATION NUMBER

Article 10.- For drug raw materials without registration number

1. Drug raw materials without registration number permitted for import into Vietnam include:

a/ Drug raw materials without registration number imported to meet drug-manufacturing establishments' demands;

b/ Drug raw materials without registration number imported in service of research and testing may be used for research or testing purposes only and in quantities suitable to these purposes;

c/ Each kind of drug raw material without registration number in Vietnam imported for registration for circulation in Vietnam may be imported in a sufficient quantity for testing requirements.

2. Imported drug raw materials are subject to a certain quality standard and have their quality conformable with the standards stated in the import orders.

3. Raw materials without registration number for the manufacture of habit-forming drugs, psychotropics and drug pre-substances must comply with this Regulation, the Health Ministry's professional regulations and other relevant legal provisions.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 11.- Transitional provisions

Permits for import of drugs without registration number already granted before the effective date of this Decision are valid till the expiration of their validity duration.

Article 12.- Implementation responsibilities

The Minister of Health shall specify dossiers, order and procedures for the grant of import permits for drugs without registration number; the quantity of drugs permitted for import in each specific case; and receive, manage and use aid or humanitarian aid drugs of foreign parties for Vietnam.